340B Rebate Program

Rebate forms may be emailed to: 340Bprogram@themedco.com
or
Forms may be completed manually and mailed to:
Nancy Navin | The Medicines Company | 8 Sylvan Way | Parsippany, NJ 07054

340B Rebate Form
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340B Rebate Worksheet
 • Download a printable copy:   [ Excel]    [ PDF]

Dear Customer:
Thank you for inquiring about retroactive 340B rebates for Angiomax® and Cleviprex®. 
The Medicines Company began participation in the 340B Program as of December 21, 2009.  We are offering to provide 340B covered entities with an appropriate refund for past 340B purchases of Angiomax® and Cleviprex® to the extent covered entities made purchases which qualified for the 340B program under the applicable federal statute and program guidance.

Covered entities may only purchase product under the 340B program for “patients” of the covered entity.¹ Under 340B program guidance, an individual is considered a “patient” of the covered entity if the following conditions are met:

• The covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual’s healthcare;
• The individual receives health care services from a health care professional who is either employed by or under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity; and
• (For hospitals) The individual is treated in an outpatient facility that is reimbursable on the hospital’s Medicare cost report.² 

Some patients may have been treated with our products during a “23 hour admission” or an “observation stay”.  It is our position that such patients are considered outpatients for 340B program purposes (subject to the other requirements listed above) when the admission meets the applicable payor requirements to be covered as an outpatient stay.³

In order to evaluate and process your refund request, we ask that you submit the following information on the attached form:

• Invoice number, date of purchase, and purchase price relating to the product for which you are requesting a refund;
• Number of boxes of each NDC purchased for appropriate use under the 340B program; and
• Name of the wholesaler from whom you purchased the product.

As the 340B ceiling price is a quarterly price, we will evaluate your request and determine the appropriate credit amount based on the quarter in which the sales were made.  Approved credits amounts will be the purchase price less the 340B ceiling price as calculated for the applicable quarter.  MDCO maintains the right under the federal statute to audit covered entities when there is reasonable cause to believe refunds are being requested for individuals who are not considered “patients” of the covered entity under applicable program guidance.

Approved credits are expected to be processed by the 340B Prime Vendor Program and will be applied towards your 340B pharmacy account with your authorized wholesaler. These credits can be utilized against future 340B purchases. MDCO will inform you of the approved credit amount in a separate communication.

Please include with your submission the attached statement, signed by an authorized representative of your organization. All requests for 340B partial refunds must be submitted by e-mailing to 340Bprogram@themedco.com or mailing to the following address by August 31, 2010:

The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
Attn: Nancy Navin

Please contact Nancy Navin at nancy.navin@themedco.com or (973) 290-6056 if you have further questions.  Thank you for your interest in Angiomax® and Cleviprex®, and we look forward to working with the U.S. Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs and the 340B community on this important program.

Regards,

Brent Furse
Senior Vice President & GM Global Commercial Operations

________________________

1. 42 U.S.C. 256b(a)(5)(B).
2. See 61 Fed. Reg. 55156, 55157 (Oct. 24, 1996), 59 Fed. Reg. 47884, 47886 (Sept. 19, 1994).
3. See e.g., Medicare Claims Processing Manual, Chapter 4, § 290.